J Hepatobiliary Pancreat Surg (2007) 14:110 DOI 10.

1007/s00534-006-1150-0

Background: Tokyo Guidelines for the management of acute cholangitis and cholecystitis
Tadahiro Takada1, Yoshifumi Kawarada2, Yuji Nimura3, Masahiro Yoshida1, Toshihiko Mayumi4, Miho Sekimoto5, Fumihiko Miura1, Keita Wada1, Masahiko Hirota6, Yuichi Yamashita7, Masato Nagino3, Toshio Tsuyuguchi8, Atsushi Tanaka9, Yasutoshi Kimura10, Hideki Yasuda11, Koichi Hirata10, Henry A. Pitt12, Steven M. Strasberg13, Thomas R. Gadacz14, Philippus C. Bornman15, Dirk J. Gouma16, Giulio Belli17, and Kui-Hin Liau18
Department of Surgery, Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605, Japan Mie University School of Medicine, Mie, Japan 3 Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan 4 Department of Emergency Medicine and Intensive Care, Nagoya University School of Medicine, Nagoya, Japan 5 Department of Healthcare Economics and Quality Management, Kyoto University Graduate School of Medicine, School of Public Health, Kyoto, Japan 6 Department of Gastroenterological Surgery, Kumamoto University Graduate School of Medical Science, Kumamoto, Japan 7 Department of Surgery, Fukuoka University Hospital, Fukuoka, Japan 8 Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan 9 Department of Medicine, Teikyo University School of Medicine, Tokyo, Japan 10 First Department of Surgery, Sapporo Medical University School of Medicine, Sapporo, Japan 11 Department of Surgery, Teikyo University Chiba Medical Center, Chiba, Japan 12 Department of Surgery, Indiana University School of Medicine, Indianapolis, USA 13 Department of Surgery, Washington University in St Louis and Barnes-Jewish Hospital, St Louis, USA 14 Department of Gastrointestinal Surgery, Medical College of Georgia, Georgia, USA 15 Division of General Surgery, University of Cape Town, Cape Town, South Africa 16 Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands 17 General and HPB Surgery, Loreto Nuovo Hospital, Naples, Italy 18 Department of Surgery, Tan Tock Seng Hospital / Hepatobiliary Surgery, Medical Centre, Singapore
2 1

Abstract There are no evidence-based-criteria for the diagnosis, severity assessment, of treatment of acute cholecysitis or acute cholangitis. For example, the full complement of symptoms and signs described as Charcots triad and as Reynolds pentad are infrequent and as such do not really assist the clinician with planning management strategies. In view of these factors, we launched a project to prepare evidence-based guidelines for the management of acute cholangitis and cholecystitis that will be useful in the clinical setting. This research has been funded by the Japanese Ministry of Health, Labour, and Welfare, in cooperation with the Japanese Society for Abdominal Emergency Medicine, the Japan Biliary Association, and the Japanese Society of Hepato-Biliary-Pancreatic Surgery. A working group, consisting of 46 experts in gastroenterology, surgery, internal medicine, emergency medicine, intensive care, and clinical epidemiology, analyzed and examined the literature on patients with cholangitis and cholecystitis in order to produce evidence-based guidelines. During the investigations we found that there was a lack of high-level evidence, for treatments, and the working group formulated the guidelines by obtaining consensus, based on evidence categorized by level, according to the Oxford Centre for Evidence-Based Medicine Levels of Evidence of May 2001 (version 1). This

work required more than 20 meetings to obtain a consensus on each item from the working group. Then four forums were held to permit examination of the Guideline details in Japan, both by an external assessment committee and by the working group participants (version 2). As we knew that the diagnosis and management of acute biliary infection may differ from country to country, we appointed a publication committee and held 12 meetings to prepare draft Guidelines in English (version 3). We then had several discussions on these draft guidelines with leading experts in the eld throughout the world, via e-mail, leading to version 4. Finally, an International Consensus Meeting took place in Tokyo, on 12 April, 2006, to obtain international agreement on diagnostic criteria, severity assessment, and management. Key words Cholangitis Cholecystitis Charcots triad Reynolds pentad Biliary drainage

Introduction No guidelines focusing on the management of biliary infection (cholangitis and cholecystitis) have previously been published, and no worldwide criteria exist for diagnostic and severity assessment. Charcots triad1 is still used for the diagnosis of acute cholangitis. How-

Offprint requests to: T. Takada Received: May 31, 2006 / Accepted: August 6, 2006

T. Takada et al.: Background of Tokyo Guidelines

ever, these criteria were rst proposed in 1877 (level 4), more than 100 years ago. Here, and throughout the series, levels of evidence are stated for referenced articles in accordance with the Oxford Centre for EvidenceBased Medicine Levels of Evidence of May 2001 (see Table 1). However only 50%70% of cholangitis patients present clinically with Charcots triad.28 In addition, Murphys sign9 (level 5) is useful (sensitivity of 50%70% and specicity of 79%96%) in diagnosing cholecystitis, and this sign is widely used in every country. Moreover, as many of the symptoms and concepts of these diseases referred to in textbooks and reference books vary from those originally stated, the issue of worldwide criteria is problematic. In view of these unfavorable situations, we considered it necessary to clarify the denitions, concepts of disease, and treatment methods for acute cholangitis and acute cholecystitis and establish universal criteria that can be widely recognized and used. A working group to establish practical Guidelines for the Management of Cholangitis and Cholecystitis was organized in 2003 (chief researcher, Tadahiro Takada). This project was funded by a grant from the Japanese Ministry of Health, Labour, and Welfare, and was supported by the Japanese Society for Abdominal Emergency Medicine, the Japan Biliary Association, and the Japanese Society of Hepato-Biliary-Pancreatic Surgery. The working group consisted of physicians engaged in gastroenterology, internal medicine, surgery, emergency medicine, intensive care, and clinical epidemiology as the main members, and they started the work to prepare the Guidelines. As the research progressed, the group was faced with the serious problem that high-level evidence regarding the treatment of acute biliary infection is poor. Therefore, an exective committee meeting was convened, and the committee came to the following decision: the Guidelines would be evidence-based in general, but areas without evidence or with poor evidence (such as diagnosis and severity assessment) should be completed by obtaining high-level consensus among experts worldwide. We established a publication committee and held 12 meetings to prepare draft Guidelines in English (version 3). Then we had several discussions on these draft Guidelines with leading experts in the eld throughout the world, via e-mail, leading to version 4. Finally, an International Consensus Meeting took place in Tokyo, on 12 April, 2006, to obtain international agreement on diagnostic criteria, severity assessment, and management. We now publish the Tokyo Guidelines for the Management of Cholangitis and cholecystitis. These Guidelines consist of 13 articles, including Discussion sections containing comments of attendees at the con-

sensus conference and analyses of audience voting at the meeting. We hope that these Guidelines will help their users to give optimal treatment according to their own specialty and capability, and thus provide their patients with the best medical treatment.

Background of Tokyo Guidelines Biliary infections (acute cholangitis and cholecystitis) require appropriate management in the acute phase. Serious acute cholangitis may be lethal unless it is appropriately managed in the acute phase. On the other hand, although various diagnostic and treatment methodologies have been developed in recent years, they have not been assessed objectively and none of them has been established as a standard method for the management of these diseases. We carried out an extensive review of the English-language literature and found that there was little high-level evidence in this eld, and no systematically described practical manual for the eld. Most importantly, there are no standardized diagnostic criteria and severity assessments for acute cholangitis and cholecystitis, therefore, we would like to establish standards for these items. The Tokyo Guidelines include evidence-based medicine and reect the international consensus obtained through earnest discussions among professionals in the eld on 12 April, 2006, at the Keio Plaza Hotel, Tokyo, Japan. Concerning the denitions in the practice guidelines, we have applied to the Japanese Institute of Medicine: Committee to Advise the Public Health Service on Clinical Practice Guidelines, to approve the systematically developed Guidelines to assist practioner and patient decisions about appropriate healthcare for specic clinical circumstances.

Notes on the use of the Guidelines The Guidelines are evidence-based, with the grade of recommendation also based on the evidence. The Guidelines also present the diagnostic criteria for and severity assessment of acute biliary infection. As the Guidelines address so many different subjects, indices are included at the end for the convenience of readers. The practice Guidelines promulgated in this work do not represent a standard of practice. They are suggested plans of care, based on best available evidence and the consensus of experts, but they do not exclude other approaches as being within the standard of practice. For example, they should not be used to compel adherence to a given method of medical management, which meth-

T. Takada et al.: Background of Tokyo Guidelines

od should be nally determined after taking account of the conditions at the relevant medical institution (staff levels, experience, equipment, etc.) and the characteristics of the individual patient. However, responsibility for the results of treatment rests with those who are directly engaged therein, and not with the consensus group. The doses of medicines described in the text of the Guidelines are for adult patients.

Methods of formulating the guidelines With evidence-based medicine (EBM) as a core concept, the Guidelines were prepared by the Research Group on the Preparation and Diffusion of Guidelines for the Management of Acute Cholangitis and Acute Cholecystitis (chief researcher, Tadahiro Takada), under the auspices of the Japanese Ministry of Health, Labour, and Welfare, and the Working Group for Guideline Preparation, whose members were selected from experts in abdominal emergency medicine and epidemiology by the Japanese Society for Abdominal Emergency Medicine, the Japan Biliary Association, and the Japanese Society of Hepato-Biliary-Pancreatic Surgery. In principle, the preparation of the Guidelines progressed with the systematic search, collection, and assessment of references for the objective extraction of evidence. Next, the External Assessment Committee examined the Guidelines. Then we posted the draft guidelines on our website and had four open symposia, bginning in September 2004, to gain feedback for further review. Subsequently, a Publication Committee was set up, and this committee had 12 meetings to prepare draft Guidelines. Re-examination of the draft Guidelines was then performed, via e-mail, with experts on cholangitis and cholecystitis throughout the world. After nal agreement was reached at the International Consensus Meeting, held in Tokyo in April 2006, the Tokyo Guidelines for the Management of Acute Cholangitis and Cholecystitis were completed. The process of extending the literature search The literature was selected as follows: Using cholangitis and cholecystitis as the medical subject heading (MeSH; explode) or the key search words, approximately 17 200 items were selected from Medline (Ovid; 1966 to June 2003). These articles were subjected to a further screening with human as the limiting word. This screening provided 9618 items in English and in Japanese. A further 7093 literature publications were obtained from the Japana Centra Revuo Medicina (internet version), using cholangitis, cholecystitis, and biliary infection as the key words, with further

screening with human as the limiting word. This process provided 6141 items. After the titles and abstracts of a total of 15 759 works were examined by two committee members, 2494 were selected for a careful examination of their full texts. Other literature quoted in these selected works, together with works suggested by the specialist committee members, were included in the examination. To evaluate each article, a STARD (standards for reporting of diagnostic accuracy) checklist (Table 1)12 was considered important. The purpose of this checklist is to evaluate the format and study process, in order to improve the accuracy and completeness of the reporting of studies of diagnostic accuracy. However, the STARD checklist is not suitable for classifying various categories (e.g., therapy, prevention, etiology, harm, prognosis, diagnosis, differential diagnosis, economic and decision analysis) and levels of evidence. Therefore, in the Guidelines, the science-based classication used by the Cochrane Library (Table 2) was adopted. The evidence obtained from each item of reference was evaluated in accordance with the science-based classication used by the Cochrane Library (Table 2), and the quality of evidence for each parameter associated with the diagnosis and treatment of acute biliary infection was determined. As stated above, the level of evidence presented by each article was determined in accordance with the Oxford Centre for Evidence-Based Medicine Levels of Evidence (May 2001), prepared by Phillips et al.13 (Table 2). The terms used in the categories are explained in the footnote to Table 2. Categories of evidence and grading of recommendations Based on the results obtained from these procedures, grades of recommendation were determined, according to the system for ranking recommendations in clinical guidelines1416 shown in Table 3, and mentioned, as required, in the text of the Guidelines. The grades of recommendation in the Guidelines are based on the Kish14 method of classication and others.15,16 Recommendations graded A (that is, do it) and B (that is, probably do it), are based on a high level of evidence, whereas those graded D (that is, probably dont do it) or E (that is, dont do it) reect a low level of evidence. Acknowledgments. We would like to express our deep gratitude to the Japanese Society for Abdominal Emergency Medicine, the Japan Biliary Association, and the Japanese Society of Hepato-Biliary-Pancreatic Surgery, who provided us with great support and guidance in the preparation of the Guidelines. This process was conducted as part of the project for the Preparation and

T. Takada et al.: Background of Tokyo Guidelines

Table 1. STARD checklist for the reporting of studies of diagnostic accuracy Section and topic Title/Abstract/ Key words Introduction Methods Participants Item no. 1 2 3 4 5 6 Test methods 7 8 9 10 11 Statistical methods Results Participants 12 13 14 15 16 Test results 17 18 19 20 21 22 23 Discussion 24 25 Identify the article as a study of diagnostic accuracy (recommend MeSH heading sensitivity and specicity) State the research questions or study aims, such as estimating diagnostic accuracy or comparing accuracy between tests or across participant groups Describe The study population: the inclusion and exclusion criteria, setting and locations where the data were collected Participant recruitment: was recruitment based on presenting symptoms, results from previous tests, or the fact that the participants had received the index tests or the reference standard? Participant sampling: was the study population a consecutive series of participants dened by the selection criteria in items 3 and 4? If not, specify how participants were further selected Data collection: was data collection planned before the index test and reference standard were performed (prospective study) or after (retrospective study)? The reference standard and its rationale Technical specications of material and methods involved, including how and when measurements were taken, and/or cite references for index tests and reference standard Denition of and rationale for the units, cutoffs, and/or categories of the results of the index tests and the reference standard The number, training, and expertise of the persons executing and reading the index tests and the reference standard Whether or not the readers of the index tests and reference standard were blind (masked) to the results of the other test, and describe any other clinical information available to the readers Methods for calculating or comparing measures of diagnostic accuracy, and the statistical methods used to quantify uncertainty (e.g., 95% condence intervals) Methods for calculating test reproducibility, if done Report When study was done, including beginning and ending dates of recruitment Clinical and demographic characteristics of the study population (e.g., age, sex spectrum of presenting symptoms, comorbidity, current treatments, recruitment centers) The number of participants satisfying the criteria for inclusion that did or did not undergo the index tests and/or the reference standard; describe why participants failed to receive either test (a ow diagram is strongly recommended) Time interval from the index tests to the reference standard, and any treatment administered between Distribution of severity of disease (dene criteria) in those with the target condition; other diagnoses in participants without the target condition A cross-tabulation of the results of the index tests (including indeterminate and missing results) by the results of the reference standard; for continuous results, the distribution of the test results by the results of the reference standard Any adverse events from performing the index tests or the reference standard Estimates of diagnostic accuracy and measures of statistical uncertainty (e.g., 95% condence intervals) How indeterminate results, missing responses, and outliers of the index tests were handled Estimates of variability of diagnostic accuracy between subgroups of participants, readers, or centers, if done Estimates of test reproducibility, if done Discuss the clinical applicability of the study ndings On page no.

Estimates

Adapted from reference 12 MeSH, medical subject heading; STARD, standards for reporting of diagnostic accuracy

Table 2. Categories of evidence (refer to levels of evidence and grades of recommendations on the homepage of the Centre for Evidence-Based Medicine)

The science-based classication used by the Cochrane Library: Oxford Centre for Evidence-based Medicine Levels of Evidence (May 2001) (http://www.cebm.net/levels_of_ evidence.asp#levels)13 was used as a basis to evaluate evidence presented in each article; the quality of evidence for each parameter associated with the diagnosis and treatment of acute cholangitis and acute cholecystitis was determined

Level SR (with homogeneitya) of inception cohort studies; CDRb validated in different populations Individual inception cohort study with >80% follow-up; CDRb validated in a single population All or none case-series SR (with homogeneitya) of either retrospective cohort studies or untreated control groups in RCTs Retrospective cohort study or follow-up of untreated control patients in an RCT; Derivation of CDRb or validated on split-samplej only Outcomes research SR (with homogeneitya) of 3b and better studies Non-consecutive study; or without consistently applied reference standards Exploratoryd cohort study with goode reference standards; CDRb after derivation, or validated only on split-samplej or databases SR (with homogeneitya) of level >2 diagnostic studies Absolute SpPins and SnNoutsh All or none case-series SR (with homogeneitya) of 2b and better studies Validatingd cohort study with goode reference standards; or CDRb tested within one clinical center Prospective cohort study with good follow-upf SR (with homogeneitya) of level 1 diagnostic studies; CDRb with 1b studies from different clinical centers SR (with homogeneitya) of prospective cohort studies

Therapy/prevention, aetiology/harm Prognosis Diagnosis

Differential diagnosis/symptom prevalence study

Economic and decision analyses SR (with homogeneitya) of level 1 economic studies

1a

SR (with homogeneitya) of RCTs

T. Takada et al.: Background of Tokyo Guidelines

1b

Individual RCT (with narrow condence intervalc)

Analysis based on clinically sensible costs or alternatives; systematic review(s) of the evidence; and including multi-way sensitivity analyses Absolute better-value or worse-value analysesi SR (with homogeneitya) of level >2 economic studies

1c

All or noneg

2a

SR (with homogeneitya) of cohort studies

2b

Individual cohort study (including low-quality RCT; e.g., <80% follow-up)

Retrospective cohort study, or poor follow-up

Analysis based on clinically sensible costs or alternatives; limited review(s) of the evidence, or single studies; and including multi-way sensitivity analyses Ecological studies SR (with homogeneitya) of 3b and better studies Non-consecutive cohort study, or very limited population Audit or outcomes research SR (with homogeneitya) of 3b and better studies Analysis based on limited alternatives or costs, poor-quality estimates of data, but including sensitivity analyses incorporating clinically sensible variations

2c

Outcomes research; ecological studies

3a

SR (with homogeneitya) of case-control studies

3b

Individual case-control study

Table 2. Continued

Level Case-series (and poor-quality prognostic cohort studiesl) Expert opinion without explicit critical appraisal, or based on physiology, bench research, or rst principles Expert opinion without explicit critical appraisal, or based on physiology, bench research, or rst principles Expert opinion without explicit critical appraisal, or based on physiology, bench research, or rst principles Case-control study, poor or non-independent reference standard Case-series or superseded reference standards

Therapy/prevention, aetiology/harm Prognosis Diagnosis

Differential diagnosis/symptom prevalence study Economic and decision analyses

Case-series (and poor-quality cohort and case-control studiesk)

Analysis with no sensitivity analysis

Expert opi\nion without explicit critical appraisal, or based on physiology, bench research, or rst principles

Expert opinion without explicit critical appraisal, or based on economic theory or rst principles

Users can add a minus-sign to denote the level that fails to provide a conclusive answer because of: EITHER a single result with a wide condence interval (such that, for example, an ARR in an RCT is not statistically signicant but whose condence intervals fail to exclude clinically important benet or harm) (Note #1), OR a systematic review with troublesome (and statistically signicant) heterogeneity (Note #2). Such evidence is inconclusive, and therefore can only generate grade D recommendations (Note #3) SR, Systematic review; RCT, Randomized controlled trial; ARR, absolute risk reduction a By homogeneity, we mean a systematic review that is free of worrisome variations (heterogeneity) in the directions and degrees of results between individual studies. Not all systematic reviews with statistically signicant heterogeneity need be worrisome, and not all worrisome heterogeneity need be statistically signicant. As noted above, studies displaying worrisome heterogeneity should be tagged with a at the end of their designated level b Clinical decision rule. These are algorithms or scoring systems which lead to a prognostic estimation or a diagnostic category c See note #2 for advice on how to understand, rate, and use trials or other studies with wide condence intervals d Validating studies test the quality of a specic diagnostic test, based on prior evidence. An exploratory study collects information and trawls the data (e.g., using a regression analysis) to nd which factors are signicant e Good reference standards are independent of the test, and are applied blindly or objectively to all patients. Poor reference standards are haphazardly applied, but still independent of the test. Use of a nonindependent reference standard (where the test is included in the reference, or where the testing affects the reference) implies a level 4 study f Good follow-up in a differential diagnosis study is >80%, with adequate time for alternative diagnoses to emerge (e.g., 16 months, acute; 15, years, chronic) g Met when all patients died before the Rx became available, but some now survive on it; or when some patients died before the Rx became available, but none now die on it h An absolute SpPin is a diagnostic nding whose specicity is so high that a positive result rules-in the diagnosis. An absolute SnNout is a diagnostic nding whose sensitivity is so high that a negative result rules-out the diagnosis i Better-value treatments are clearly as good but cheaper, or better at the same or reduced cost. Worse-value treatments are as good and more expensive, or worse and equally or more expensive j Split-sample validation is achieved by collecting all the information in a single tranche, then articially dividing this into derivation and validation samples k By poor-quality cohort study, we mean one that failed to clearly dene comparison groups and/or failed to measure exposures and outcomes in the same (preferably blinded), objective way in both exposed and nonexposed individuals, and/or failed to identify or appropriately control known confounders, and/or failed to carry out a sufciently long and complete follow-up of patients. By poor-quality case-control study, we mean one that failed to clearly dene comparison groups and/or failed to measure exposures and outcomes in the same (preferably blinded), objective way in both cases and controls and/or failed to identify or appropriately control known confounders l By poor-quality prognostic cohort study, we mean one in which sampling was biased in favor of patients who already had the target outcome, or the measurement of outcomes was accomplished in <80% of study patients, or outcomes were determined in an unblinded, nonobjective way, or there was no correction for confounding factors Good, better, bad, and worse refer to the comparisons between treatments in terms of their clinical risks and benets

T. Takada et al.: Background of Tokyo Guidelines

T. Takada et al.: Background of Tokyo Guidelines Table 3. Grading system for ranking recommendations in clinical guidelines1416 Grade of recommendation A B C D E

Good evidence to support a recommendation for use Moderate evidence to support a recommendation for use Poor evidence to support a recommendation, or the effect may not exceed the adverse effects and/or inconvenience (toxicity, interaction between drugs and cost) Moderate evidence to support a recommendation against use Good evidence to support a recommendation against use

Diffusion of Guidelines for the Management of Acute Cholangitis (H-15-Medicine-30), with a research subsidy for scal 2003 and 2004 (Integrated Research Project for Assessing Medical Technology) sponsored by the Japanese Ministry of Health, Labour, and Welfare. We also truly appreciate the panelists who cooperated with and contributed signicantly to the International Consensus Meeting held in Tokyo on April 1 and 2, 2006.

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1. Charcot M. De la evre hepatique symptomatique. Comparaison avec la evre uroseptique. Lecons sur les maladies du foie des voies biliares et des reins. Pairs: Bourneville et Sevestre; 1877. p. 17685. 2. Boey JH, Way LW. Acute cholangitis. Ann Surg 1980;191:26470. (level 4) 3. OConnor MJ, Schwartz ML, McQuarrie DG, Sumer HW. Acute bacterial cholangitis: an analysis of clinical manifestation. Arch Surg 1982;117:43741. (level 4) 4. Lai EC, Tam PC, Paterson IA, Ng MM, Fan ST, Choi TK, et al. Emergency surgery for severe acute cholangitis. The high-risk patients. Ann Surg 1990;211:559. (level 4) 5. Haupert AP, Carey LC, Evans WE, Ellison EH. Acute suppurative cholangitis. Experience with 15 consecutive cases. Arch Surg 1967;94:4608. (level 4) 6. Csendes A, Diaz JC, Burdiles P, Maluenda F, Morales E. Risk factors and classication of acute suppurative cholangitis. Br J Surg 1992;79:6558. (level 2b) 7. Welch JP, Donaldson GA. The urgency of diagnosis and surgical treatment of acute suppurative cholangitis. Am J Surg 1976;131: 52732. (level 4) 8. Chijiiwa K, Kozaki N, Naito T, Kameoka N, Tanaka M. Treatment of choice for choledocholithiasis in patients with acute obstructive suppurative cholangitis and liver cirrhosis. Am J Surg 1995;170:35660. (level 2b) 9. Murphy JB. The diagnosis of gall-stones. Am Med News 82:82533. 10. Eskelinen M, Ikonen J, Lipponen P. Diagnostic approaches in acute cholecystitis; a prospective study of 1333 patients with acute abdominal pain. Theor Surg 1993;8:1520. (level 2b) 11. Trowbridge RL, Rutkowski NK, Shojania KG. Does this patient have acute cholecystitis? JAMA 289:806. (level 3b)

12. Bossuyt PM, Reitsma JB, Bruns DE, Glaziou CA, Irwig LM, Lijmer JG, et al., for the STARD Group; STARD checklist for the reporting of studies of diagnostic accuracy. Ann Int Med 2003;138:40-E-45. 13. Phillips B, et al. Levels of evidence and grades of recommendations on the homepage of the Centre for Evidence-Based Medicine (http://cebm.jr2.ox.ac.uk/docs/levels.html) 2001 revised version. 14. Kish MA; Infectious Diseases Society of America. Guide to development of practice guidelines. Clin Infect Dis 2001;32:8514. 15. Mayumi T, Ura H, Arata S, Kitamura N, Kiriyama I, Shibuya K, et al. Evidence-based clinical practice guidelines for acute pancreatitis: proposals. J Hepatobiliary Pancreat Surg 2002;9:41322. 16. Takada T, Hirata K, Mayumi T, Yoshida M, Sekimoto M, Hirota M, et al. JPN Guidelines for the management of acute pancreatitis: the cutting edge. J Hepatobiliary Pancreat Surg 2006;13:26.

Discussion at the Tokyo International Consensus Meeting Tadahiro Takada (Japan): Dr. Strasberg, please explain the difference between a Guidelines and Standards in your mind? Steven Strasberg (USA): To me, guidelines represent a suggested course of action based on available evidence. They do not imply that other courses of action are below an acceptable level of care. Practice standards are different, in that they imply that actions other than those listed as acceptable practice standards are below the level of acceptable care. It is particularly true that, in an area in which high levels of evidence are not available, that guidelines are not construed to be standards. Reliance on expert opinion to form guidelines may be useful, but even a consensus of experts may not be correct. For this reason a statement of the following type should be inserted in the introduction. The practice guidelines promulgated in this work do not represent a standard of practice. They are a suggested plan of care based on best available evidence and a consensus of experts, but they do not exclude other approaches as being within the standard of practice.

T. Takada et al.: Background of Tokyo Guidelines

The Members of Organizing Committee and Contributors for Tokyo Guidelines

Members of the Organizing Committee of Tokyo Guidelines for the Management of Acute Cholangitis and Cholecystitis T. Takada Y. Nimura Y. Kawarada K. Hirata H. Yasuda Y. Yamashita Y. Kimura M. Sekimoto T. Tsuyuguchi M. Nagino M. Hirota T. Mayumi F. Miura M. Yoshida Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan Division of Surgical Oncology, Department of Surgery, Nagoya University, Graduate School of Medicine, Nagoya, Japan Mie University, Mie, Japan First Department of Surgery, Sapporo Medical University School of Medicine, Sapporo, Japan Department of Surgery, Teikyo University Chiba Medical Center, Chiba, Japan Department of Surgery, Fukuoka University School of Medicine, Fukuoka, Japan First Department of Surgery, Sapporo Medical University School of Medicine, Sapporo, Japan Department of Healthcare Economics and Quality Management, Kyoto University Graduate School of Medicine, Kyoto, Japan Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan Department of Gastroenterological Surgery, Kumamoto University Graduate School of Medical Sciences, Kumamoto, Japan Department of Emergency Medicine and Critical Care, Nagoya University Graduate School of Medicine, Nagoya, Japan Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan

Advisors and International Members of Tokyo Guidelines for the Management of Acute Cholangitis and Cholecystitis Department of Surgery, Kyorin University School of Medicine, Tokyo, Japan Department of Hepato-Biliary-Pancreatic / General Surgery, Tokyo Medical and Dental University, Tokyo, Japan J. Belghiti Department of Digestive Surgery & Transplantation, Hospital Beaujon, Clichy, France G. Belli Department of General and HPB Surgery, Loreto Nuovo Hospital, Naples, Italy P.C. Bornman Division of General Surgery, University of Cape Town, Cape Town, South Africa M.W. Bchler Department of General Surgery, University of Heidelberg, Germany A.C.W. Chan Director Endoscopy Centre, Specialist in General Surgery, Minimally Invastive Surgery Centre M.F. Chen Chang Gung Memorial Hospital, Chang Gung Medical University, Taiwan X.P. Chen Department of Surgery, Tongji Hunter College, Tongji Hospital Hepatic Surgery Centre, China E.D. Santibanes HPB and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Argentina C. Dervenis First Department of Surgery, Agia Olga Hospital, Greece S. Dowaki Department of Digestive Surgery, Tokai University Tokyo Hospita, Kanagawa, Japan S.T. Fan Department of Surgery, The University of Hong Kong Medicak Centre, Queen Mary Hospital, Hong Kong H. Fujii 1st Department of Surgery, University of Yamanashi Faculty of Medicine, Yamanashi, Japan T.R. Gadacz Gastrointestinal Surgery, Medical College of Georgia, USA D.J. Gouma Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands N. Abe S. Arii

T. Takada et al.: Background of Tokyo Guidelines

S.C. Hilvano S. Isaji M. Ito T. Kanematsu N. Kano C.G. Ker M.H. Kim S.W. Kim W. Kimura S. Kitano E.C.S. Lai J.W.Y. Lau K.H. Liau S. Miyakawa K. Miyazaki H. Nagai T. Nakagohri H. Neuhaus T. Ohta K. Okamoto R.T. Padbury B.B. Philippi H.A. Pitt M. Ryu V. Sachakul M. Shimazu T. Shimizu K. Shiratori H. Singh J.S. Solomkin S.M. Strasberg K. Suto A.N. Supe M. Tada S. Takao H. Takikawa M. Tanaka S. Tashiro S. Tazuma M. Unno G. Wanatabe

Department of Surgery, College of Medical & Philippine General Hospital, Philippines Department of Hepato-Biliary-Pancreatic Surgery, Mie University Graduate School of Medicine, Mie, Japan Department of Surgery, Fujita Health University, Nagoya, Japan Second Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan Special Adviser to the President, Chairman of Department of Surgery and Director of Endoscopic Surgical Center, Kameda Medical Center, Chiba, Japan Division of HPB Surgery, Yuans General Hospital, Taiwan Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Korea Department of Surgery, Seoul National University College of Medicine, Korea First Department of Surgery, Yamagata University Faculty of Medicine, Yamagata, Japan First Department of Surgery, Oita University Faculty of Medicine, Oita, Japan Pedder Medical Partners, Hong Kong Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong Department of Surgery, Tan Tock Seng Hospital/Hepatobiliary Surgery, Singapore Department of Surgery, Fujita Health University, Nagoya, Japan Department of Surgery, Saga Medical School, Saga University Faculty of Medicine, Saga, Japan Department of Surgery, Jichi Medical School, Tokyo, Japan Department of Surgery, National Cancer Center Hospital East, Chiba, Japan Internal Medicine Evangelisches Krankenhaus Dusseldorf, Germany Department of Digestive Surgery, Kanazawa University Hospital, Ishikawa, Japan First Department of Surgery, School of Medicine, University of Occupational and Environmental Health, Fukuoka, Japan Department of Surgery, The Flinders University of South Australia GPO, Australia) Department of Surgery, University of Indonesia, Cipto Mangunkusumo National Hospital, Jakarta, Indonesia Department of Surgery, Indiana University School of Medicine, USA Chiba Cancer Center, Chiba, Japan Department of Surgery, Phramongkutklao College of Medecine, Thailand Department of Surgery, Keio University School of Medicine, Tokyo, Japan Department of Surgery, Nagaoka Chuo General Hospital, Niigata, Japan Department of Digestive tract internal medicine, Tokyo Womens Medical University, Tokyo, Japan Department of HPB Surgery, Selayang Hospital, Malaysia Department of Surgery, University of Cincinnati College of Medicine Cincinnati, Ohio, USA Department of Surgery, Washington University in St Louis and Barnes-Jewish Hospital, USA Department of Surgery, Yamagata University Faculty of Medicine, Yamagata, Japan Department of Surgical Gastroenterology, Seth G S Medical College and K E M Hospital, India Department of Digestive tract internal medicine, Graduate School of Medicine University of Tokyo, Tokyo, Japan Research Center for life science resources, Kagoshima University Faculty of Medicine, Kagoshima, Japan Teikyo University School of Medicine, Tokyo, Japan Department of Surgery and Oncology, Graduate School of Medical Sciences Kyushu University, Fukuoka, Japan Shikoku Central Hospital, Ehime, Japan Department of Primary Care Medicine, Hiroshima University School of Medicine, Hiroshima, Japan Department of Digestive Surgery, Tohoku University Graduate School of Medicine, Miyagi, Japan Department of Digestive Surgery, Toranomon Hospital Tokyo, Tokyo, Japan

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T. Takada et al.: Background of Tokyo Guidelines

J.A. Windsor H. Yamaue

Department of General Surgery, Auckland Hospital, New Zealand Second Department of Surgery, Wakayama Medical University School of Medicine, Wakayama, Japan

Working group of the Guidelines for the Management of Acute Cholangitis and Cholecystitis M. Mayumi M. Yoshida T. Sakai N. Abe M. Ito H. Ueno M. Unno Y. Kimura M. Sekimoto S. Dowaki N. Nago J. Hata M. Hirota F. Miura Y. Ogura A. Tanaka T. Tsuyuguchi M. Nagino K. Suto T. Ohta I. Endo Y. Yamashita S. Yokomuro Department of Emergency Medicine and Critical Care, Nagoya University School of Medicine, Nagoya, Japan Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan Kyoto Katsura Hospital, General Internal Medicine, Kyoto, Japan Department of Surgery, Kyorin University School of Medicine, Tokyo, Japan Department of surgery, Fujita-Health University, Aichi, Japan Department of Emergency and Critical Care Medicine, Graduate School of Medicine, Chiba University, Chiba, Japan Department of Surgery, Tohoku University Graduate School of Medical Science, Sendai, Japan First Department of Surgery, Sapporo Medical University School of Medicine, Sapporo, Japan Department of Healthcare Economics and Quality Management, Kyoto University Graduate School of Medicine, Kyoto, Japan Department of Surgery, Tokai University School of Medicine, Kanagawa, Japan Japanese Association for Development of Community Medicine, Yokosuka Uwamachi Hospital, Yokosuka, Japan Department of Laboratory Medicine, Kawasaki Medical School, Kurashiki, Japan Department of Gastroenterological Surgery, Kumamoto University Graduate School of Medical Sciences, Kumamoto, Japan Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan Department of Pediatric Surgery, Nagoya University School of Medicine, Nagoya, Japan Department of Medicine, Teikyo University School of Medicine, Tokyo, Japan Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan Department of Gastroenterological and General Surgery, Course of Organ Functions and Controls, Yamagata University School of Medicine, Yamagata, Japan Department of Surgery, Institute of Gastroenterology, Tokyo Womens Medical University, Tokyo, Japan Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, Yokohama, Japan Department of Surgery, Fukuoka University Hospital, Fukuoka, Japan Nippon Medical School, Graduate School of Medicine Surgery for Organ Function and Biological Regulation, Tokyo, Japan

Members of the External Evaluation Committee T. Fukui Y. Imanaka Y. Sumiyama T. Shimizu H. Saisho K. Okamoto St. Lukes International Hospital, Tokyo, Japan Department of Healthcare Economics and Quality Management, Kyoto University Graduate School of Medicine, Kyoto, Japan Third Department of Surgery, Toho University School of Medicine, Tokyo, Japan Department of Surgery, Nagaoka chuo General Hospital, Nagaoka, Japan Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan First Department of Surgery, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan